Johnson & Johnson Careers
Director (m/f) of Quality Control Laboratories for EMEA
Requisition ID: 1805704236W
Johnson & Johnson is currently recruiting the Director, Global Quality Control Laboratories for our Medical Devices (MD) segment. Our Medical Devices companies, comprised of Ethicon, CSS (Cardiovascular & Specialty Solutions), and DePuy Synthes have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Strategic development and successful execution of QC testing and operating strategies for existing product portfolios as well as for new products and launch to maximize the efficiency and effectiveness of the QC laboratory operation.
- Manages supervisors who oversee daily operation of testing, project management, budget oversight, investigations and performance management.
- Establish the implementation of new technologies and processes that take forward strategies to maximize productivity and reduce testing cycle time.
- Partner effectively with R&D and MAKE to embed quality control in our supply chain processes, such as PAT (Process Analytical Technologies) and DTV (Design to Value)
- Partners with local site staff and stakeholders (R&D, Make, Source, BQ, QA, etc) and is accountable for the implementation and maintenance of key performance indicators/ metrics. Ensures that production and quality levels meet or exceed organization and customer expectations.
- Ensures alignment of regional hub with MD QC laboratories Global Laboratory Capability Centers (GLCC) as required. Works with peers and other QC leaders to deploy and embed harmonized processes through the GLCC.
- Develops and deploys cost competitiveness focus and ensures the culture of continuous improvement of business performance is strong
- Working with GLCC, ensures scalable and flexible capacity utilization, utilizing both internal and external laboratory capabilities to address changes in demand
- Manage escalation issues or testing interruptions in conjunction with the local QC lead and site QA
- Ensure strong budgetary CAPEX and OPEX management
- Responsible for communicating business related issues or opportunities to next management level
- Ensure a clear talent development strategy is implemented enabling career development, both technical and people leadership. Ensures building of new capabilities for the new product pipeline
- People management of a regionally-dispersed diverse staff and related stakeholders in quality activities to optimize favorable outcomes and ensure balanced decision-making. Fosters organizational development. Creates and drives a high level of commitment to customer service.
- Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Develops and manages budget, organizational structure and business requirements / metrics to accommodate business needs
- Performs other duties assigned as needed
- University/Bachelors degree required. Preferred field of study includes life sciences.
- 10-12 years relevant experience is required including 5 years laboratory management experience is required.
- In-depth understanding of medical devices processes and manufacturing, and GMP requirements is preferred
- Proven Experience in dealing with internal & external stakeholders, both regulatory stakeholders as well as external business partners. Good knowledge of international regulatory requirements and agencies.
- Demonstrated knowledge of GxP regulations and proven cycle of success in implementing and maintaining GMP compliance.
- Strong Interpersonal partnering capabilities with a focus on customer service and delivering results with the ability to build and nurture strong and positive relationships with Therapeutic Areas, Commercial and R&D leadership. Ability to communicate across all levels of the organization.
- In-depth understanding of medical devices processes and manufacturing, and GMP requirements
- Demonstrated business skills, including financial acumen and business planning with previous experience with budget and capacity planning (OPEX, CAPEX, headcount). Demonstrated experience in delivering business improvements projects.
- Ability to translate strategy to execution for local laboratories to ensure ability to achieve business results.
- Ability to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile and rapidly changing environment
- Knowledge of the business environment inside a quality organization across various roles
- Certification in Lean/Six Sigma an advantage
- Fluent verbal and written English communication skills; other language skills advantageous
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
- Position has direct reports, which are laboratory leads that report into the hub. May also perform lab lead responsibilities for a laboratory within the EMEA region.
- Serves several internal and external contacts
- The position will report to the Senior Director QC Laboratory
- Participate in management reviews and Quality leadership meetings within the region as applicable
- Chair laboratory performance management review meetings within the region
- Drive overall Quality control strategy in alignment with MAKE, R&D and Supply chain organization within region
LOCATION & TRAVEL REQUIREMENTS
- European and middle eastern travel with 25-30% travel with domestic reach
- Primary location is at any site in Europe or Israel
- Align with third party suppliers for consumable requirements for the region
- Review selection of the third party laboratories to conduct Quality control testing activities
Europe/Middle East/Africa, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Israel, Europe/Middle East/Africa-United Kingdom-England, Europe/Middle East/Africa-Switzerland-Basel-City-Basel
Ethicon Inc. (6045)